Overview of the Study Review Process

OVERVIEW

This Quickguide outlines the process of how a study is reviewed, including central review of the study and local context review.
 

 

Steps

STUDY CHAIR SUBMITS STUDY TO NCI

The NCI-funded networks have national Study Chairs.  These Study Chairs submit studies to NCI, specifically Cancer Therapy Evaluation Program (CTEP) or Division of Cancer Prevention (DCP), for scientific review.

Steps

PIO ISSUES "APPROVAL ON HOLD"

During the scientific review process, CTEP or DCP works directly with the Study Chair to refine the study.  Once the Study Chair and CTEP or DCP have completed their review, the Protocol Information Office (PIO) for CTEP or DCP, issues an "Approval on Hold."  At this time, the study is received by the CIRB and is pending review and approval by the CIRB.

Steps

CIRB CONDUCTS INITIAL REVIEW

Depending on the type of study (i.e., Pediatric, Adult, Phase, etc.), the study is sent to the appropriate board for review.   During review of study, the CIRB works directly with the Study Chair to ensure compliance with human subjects protection regulations.  Once the CIRB approves the study, CIRB sends an outcome letter to the Study Chair and CTEP or DCP noting that the study has been approved by the CIRB.   CIRB notifies PIO upon final CIRB approval and provides the approved consent form and protocol with Approval Letter. For more information, go to Submitting a Study for Initial Review.

Steps

NCI ISSUES FINAL APPROVAL

NCI reviews changes required by the CIRB for CIRB approval and issues a final approval to the Study Chair.

Steps

NETWORK DISTRIBUTES STUDY NATIONALLY

Once the Study Chair receives final approval, the Study Chair’s NCI-funded Network will distribute the study nationally.  The Cancer Trials Support Unit (CTSU) will also have information on most of the studies available on their website under the study’s CIRB documents tab. For more information, go to, Finding Information Q&A.

Steps

PI SUBMITS WORKSHEET TO CIRB

Once a study has been distributed, Principal Investigators at Signatory Institutions have the opportunity to open the study.  In order to open a study locally, a Principal Investigator (PI) has to be at a Signatory Institution enrolled in the CIRB and the PI must have an approved Principal Investigator Worksheet with the CIRB.  To open the study, the PI completes the Study-Specific Worksheet and submits it to the CIRB for review.  For more information, go to Opening a Study.

Steps

CIRB CONDUCTS LOCAL CONTEXT REVIEW

The Local Context Subcommittee of the CIRB reviews the Study-Specific Worksheet and provides a determination.

Steps

PI RECEIVES CIRB APPROVAL TO OPEN STUDY

Once the CIRB Local Context Subcommittee approves the Worksheet, the CIRB Operations Office generates the Approval Letter and sends it to PI.  Once the PI has received the Approval Letter, the study may be opened at their institution.